Protocol summary
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Study aim
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Evaluation of the effects of adolescent health promotion training package on treatment of polycystic ovary syndrome
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Design
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This study is a longitudinal clinical trial.
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Settings and conduct
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In this study, 100 adolescents with poly cystic ovary syndrome (50 in each group) were randomly selected from the students in Tehran high schools. In the intervention group the training was done by lecture method and the second group was control (no training).
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Participants/Inclusion and exclusion criteria
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inclusion criteria: 14-18 years old girls, signed written consent form by parents and student; no history of disease; no drug use, no drug addiction.
exclusion criteria: Unwillingness of the teenager or her parents to participate in the study, Lack of teen participation in one-third of educational classes,
Adolescent drug use
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Intervention groups
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Face-to-face teaching to poly cystic ovary syndrome adolescents is conducted in eight 60-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years.
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Main outcome variables
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• Changes in nutritional status score) FFQ, recall 24 h questionnaire(
• Changes in physical activity status score (Caspian questionnaire )
• Changes in the status of blood bio markers
• Changes in status of ultrasound items
• Changes in the quality of life of adolescents( kids Screening Questionnaire)
General information
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Reason for update
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Due to the conditions of school closures and changes in the implementation of this plan in Tehran girls' high schools, it is necessary to express it in this section as well.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200114046123N1
Registration date:
2020-01-23, 1398/11/03
Registration timing:
prospective
Last update:
2022-02-28, 1400/12/09
Update count:
1
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Registration date
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2020-01-23, 1398/11/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-22, 1399/07/01
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Expected recruitment end date
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2021-09-23, 1400/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary syndrome
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Public title
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Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary disease
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Written parental and student agreement
Girls ages 14 to 18 who are single and without sexual relation
At least 2 years passed from the juvenile menarche
According to ASRM criteria, 2 items of PCOS symptoms were diagnosed
Be healthy in terms of all diseases including liver, kidney, thyroid, heart and skeletal diseases
Have not taken any female hormone or metformin medication for at least three months before entering the study
Have no smoking at least three months before the intervention
Do not use drugs or alcohol
Not have severe mental illness (which requires medication)
Do not exercise professionally or attend school sports team
Do not follow a specific diet
Exclusion criteria:
Adolescents who failed to perform 1/3 of the recommended physical activities per month for any reason
Adolescents who for any reason failed to attend 1/3 of the classes held at the school.
Adolescents who have not completed any form of physical activity and diet assessment for at least one month for any reason.
Adolescents who affected by a specific illness or need to take a particular drug after entering the plan.
Adolescents who they or their parents are reluctant to continue in the project for any reason.
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Age
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From 14 years old to 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The sampling method is random cluster sampling in the educational districts of Tehran. At first Tehran are divided into five educational districts (East, West, North, South and Center). The areas in the five districts are written separately on paper and were drawn randomly. Then again, in each cluster, the girls' secondary schools are written separately on a single paper and randomly drawn. In the draw, the first school name in each district is placed in the intervention group respectively; the second school name in that district is placed in the control group (two schools in each district).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-02, 1397/04/11
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1397.100
Health conditions studied
1
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Description of health condition studied
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poly cystic ovarian syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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life style modification in adolescent with poly cystic ovarian syndrome
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Timepoint
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before intervention, 6 and 12 after intervention
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Method of measurement
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diet and physical activity questionnaire
2
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Description
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menstrual cycleregularity,
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Timepoint
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Before intervention and 6, 12 months after intervention
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Method of measurement
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Menstrual cycles are <21 or more than 35 days or have <8 cycles per year will be considered irregular
3
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Description
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Hirsutism status
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Timepoint
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Before intervention and 6, 12 months after intervention
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Method of measurement
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The Ferriman–Gallwey scale will be used for Hirsutism status; a score of 1–4 is given for nine areas of the body. A total score <9 is considered normal, a score of 9–15 indicates mild Hirsutism, and a score >15 indicates moderate or severe Hirsutism
4
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Description
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Anthropometric index
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Timepoint
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Before intervention and 6, 12 months after intervention
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Method of measurement
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weight,height, waist, and hip circumstance
Secondary outcomes
1
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Description
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Blood bio markers
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Timepoint
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before intervention and after 12 months
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Method of measurement
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Blood test
2
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Description
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Sonography Items
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Timepoint
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before intervention and after 12 months
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Method of measurement
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Transabdominal Sonography
Intervention groups
1
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Description
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"Intervention group:" Face-to-face teaching polycystic ovary syndrome adolescents are conducted in eight 45-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years.
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Category
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Lifestyle
2
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Description
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"Control group: " The control group receive only routine care and receive no intervention and training packages. Routine care includes blood pressure control, weight measurement, blood biomarkers and ultrasound measurement.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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one report include: introduction, methods, results and discussion
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When the data will become available and for how long
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12 months after published manuscript
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To whom data/document is available
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Academic researchers are allowed access to data
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Under which criteria data/document could be used
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Citing the source
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From where data/document is obtainable
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Correspondence with responsible author by email
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What processes are involved for a request to access data/document
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The application letter should include the name of the applicant, the use and the scientific title of the research project or article in question.
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Comments
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